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Peer-reviewedCC BY-NC 4.0Medical Devices (Auckland, N.Z.)

Topic Modeling and Content Analysis of Chinese Medical Device Policies Using BERTopic

  • Xin Lu1,2,3
  • Jiawei Chen4
  • Yang Miao5,6
6 affiliations
  1. 1Zhejiang Institute of Medical Device Supervision and Testing, Hangzhou, People’s Republic of China
  2. 2NMPA Key Laboratory for Biomedical Optics, Hangzhou, People’s Republic of China
  3. 3Key Laboratory of Safety Evaluation of Medical Devices of Zhejiang Province, Hangzhou, People’s Republic of China
  4. 4School of Business, Jiangnan University, Wuxi, People’s Republic of China
  5. 5School of Public Administration, Zhejiang University of Technology, Hangzhou, People’s Republic of China
  6. 6School of Management, Zhejiang University of Technology, Hangzhou, People’s Republic of China
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Abstract

Purpose: Revealing the key direction and regulatory measures of medical device policies can provide a scientific basis for improving the regulatory system and promote the healthy and orderly development of the medical device industry.

Materials and Methods: Collecting 37 medical device policy (2014–2025) at the central government level, which are currently in effect or will soon come into effect, this study adopts the BERTopic model to extract topics. Through analysis of thematic content, hierarchical structures, and clusters, it provides a comprehensive decoding of Chinese medical device policy texts.

Results: A total of 17 topics have been identified in the medical device policy. Based on the correlation of the hierarchical structure of these topics, they are classified into six clusters: advertising regulations, subject qualifications and compliance requirements, application template, clinical trial management, comprehensive regulatory system, storage and transportation technical specifications.

Conclusion: The topic modeling of the policy text on medical devices reveals the focus areas, policy intentions, and regulatory priorities, providing a scientific basis for improving the regulatory framework.

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Cite

BibTeXRIS
BibTeX
@article{lu2026topic,
  title = {{Topic Modeling and Content Analysis of Chinese Medical Device Policies Using BERTopic}},
  author = {Xin Lu and Jiawei Chen and Yang Miao},
  journal = {Medical Devices (Auckland, N.Z.)},
  year = {2026},
  month = nov,
  doi = {10.2147/mder.s643805},
  url = {https://doi.org/10.2147/mder.s643805},
  note = {CC BY-NC 4.0},
}
RIS
TY  - JOUR
TI  - Topic Modeling and Content Analysis of Chinese Medical Device Policies Using BERTopic
AU  - Xin Lu
AU  - Jiawei Chen
AU  - Yang Miao
PY  - 2026
DA  - 2026/11/01
JO  - Medical Devices (Auckland, N.Z.)
DO  - 10.2147/mder.s643805
UR  - https://doi.org/10.2147/mder.s643805
AB  - Purpose: Revealing the key direction and regulatory measures of medical device policies can provide a scientific basis for improving the regulatory system and promote the healthy and orderly development of the medical device industry.  Materials and Methods: Collecting 37 medical device policy (2014–2025) at the central government level, which are currently in effect or will soon come into effect, this study adopts the BERTopic model to extract topics. Through analysis of thematic content, hierarchical structures, and clusters, it provides a comprehensive decoding of Chinese medical device policy texts.  Results: A total of 17 topics have been identified in the medical device policy. Based on the correlation of the hierarchical structure of these topics, they are classified into six clusters: advertising regulations, subject qualifications and compliance requirements, application template, clinical trial management, comprehensive regulatory system, storage and transportation technical specifications.  Conclusion: The topic modeling of the policy text on medical devices reveals the focus areas, policy intentions, and regulatory priorities, providing a scientific basis for improving the regulatory framework.
SN  - 1179-1470
ER  -